NCT02544152

Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome

A Randomized, Double-blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Lubiprostone in Adult Subjects With Mixed or Unsubtyped Irritable Bowel Syndrome (IBS-M/IBS-U)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Sucampo Pharma Americas, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.

Detailed description

To assess the efficacy and safety of oral lubiprostone, as compared to matching placebo, when administered orally (at 8 mcg twice daily \[BID\]) in subjects diagnosed with IBS-M/IBS-U.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Lubiprostone	8 mcg administered orally twice daily (BID)
DRUG	Placebo	Matching placebo, 0 mcg administered orally twice daily (BID)

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-09-09
• Last updated: 2019-12-27
• Results posted: 2019-12-27

Locations

16 sites across 1 country: United States